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Full-timeDescriptionUnder general supervision, reviews processing equipment specification used in the development of Solid Oral, semi solid, liquid and Injectable dosage form products. Provides support in the areas of project coordination and follow through, assists with problem solving, efficiency studies and identification of process improvement opportunities. Involves developing manufacturing processes for pharmaceutical products, creating and updating procedures and specifications, writing reports on documentation studies performed and results obtained.
Involvement in new product formulation, scale-up process optimization, process validation and technology transfers. Participates in the timely manufacture of supplies in support of clinical and stability programs.
JOB DUTIES & RESPONSIBILITIES
- Independently assists in formulation work in early stage research
- Oversees and coordinates development manufacturing events
- Operate general processing equipment/analytical instruments during formulation work, such as Granulator, Dryer, Blender, Tablet coater, Fluid Bed coating, HPLC, pH meter, viscometer, particle size testing etc. or any processing equipment as needed for the project.
- Perform IQ/OQ for all the equipment as needed
- Labels, transcribes and records documentation such as report sheets and laboratory notebooks as required by Standard Operating Procedures.
- Responsible for the design and development of products and process used in manufacturing from small-scale manufacturing to commercial operation.
- Analyzes and interprets protocol an experimental data to set product and process specifications.
- Analyzes existing equipment and recommends modifications when necessary for process optimization
- Presents test data and findings to management as required.
- Trains small scale- up manufacturing personnel as required
- Ability to lift up to 50 pounds.
Requirements
Minimum Education & Experience:
- Bachelor’s or Master’s degree in engineering or a related field from an accredited college or university.
- At least 2 or more years of experience in designing products/processes and installing operating and troubleshooting equipment in pharmaceutical manufacturing equipment (or food, or cosmetic manufacturing environment, or an equivalent combination of training and experience.
Required Knowledge & Skills:
- Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA),
- Drug Enforcement Agency (DEA) and other regulatory requirements.
- Engineering principles applied to the manufacturing process including mixing, coating, die-cutting, pouching, and filling processes.v
- Pharmaceutical quality control and manufacturing processes.
- Techniques of sampling, testing and measuring, and principles of mathematical and statistical computations.
- Mechanical and electrical concepts.
- English usage, spelling, grammar and punctuation.
- Personal computer operations and Microsoft applications (CAD, Word, Access, and Excel).
- Statistical process control
